Drug Development, Evaluation and Regulatory Sciences
| Numbering Code | G-GAIS00 73012 LB90 | Year/Term | 2022 ・ Second semester |
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| Number of Credits | 1 | Course Type | Lecture |
| Target Year | From 1st to 3rd year students | Target Student | |
| Language | Japanese and English | Day/Period | Wed.2 |
| Instructor name | KAWAKAMI, KOJI (Graduate School of Medicine Professor) | ||
| Outline and Purpose of the Course |
Director and Instructors: (Director) Koji Kawakami (Professor，Pharmacoepidemiology) Hiromitsu Shirasawa (MSD, Japan), Ikuo Horii (Cambridge Univ.), Izumi Sato(Professor，Nagasaki Univ. ),Christian Elze (Catenion), Yoshie Onishi(CreativCeutical),Daijiro Katsumoto(MOF), Hisashi Urushihara (Keio Univ.), Sachiko Tanaka(Program specific professor, Digital health) The efficacy and safety of the drug, biologics, and medical devices are evaluated through the drug development process involving preclinical and clinical studies, manufacturing, and post-marketing surveillance. Also, cost/benefit consideration through the comparative effective research is necessary. Fundamental considerations of these issues along with research examples will be discussed. |
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| Course Goals | To understand idea of the development, evaluation, cost/benefit of medicinal products. | ||
| Schedule and Contents |
November 16 Healthcare Systems - Challenges and Reform(Elze) November 30 Drug development and toxicity/safety (Horii) December 7 Regulatory affairs in the globalwide pharmaceutical company (Shirasawa) December 14 Medical real world data and Medicine evaluation(Kawakami) December 21 An introduction to Pharmacoepidemiology (Sato) December 28 Pharmacoeconomics and value-based drug pricing (Onishi) January 4 Postmarketing surveillance (Urushihara) January 11 Finance of Japan and healthcare (Katsumoto) January 18 Digital health and epidemiology(Tanaka) |
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| Evaluation Methods and Policy | Participation (50%) and report (50%) | ||
| Course Requirements |
You must take this course along with the course3031“Drug policy and regulation” otherwise the entire grasp of the drug research, development, and regulations will not be achieved. |
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| Study outside of Class (preparation and review) | Preparation in advance and review after lecture | ||
| References, etc. |
Invitation to new drug development., Saeko Yasuo et al., ( Kyoritsu Press, 2006 ) Strom's Textbook of Pharmacoepidemiology, Koji Kawakami, Hisashi Urushihara, Shiro Tanaka et al. ed., (NANZANDO Co.,Ltd., 2019.) |
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